FDA Radiology AI Devices

DrAid for Radiology v1 is an AI-based software tool that analyzes adult chest X-rays to identify features indicative of pneumothorax. It helps prioritize cases in the radiology workflow by notifying the system of potentially critical images, assisting clinicians in timely review without providing direct diagnoses or replacing clinical judgment.

Viz SDH is an AI-driven software designed to analyze non-contrast CT scans of the head to detect subdural hemorrhages. It provides rapid notifications of suspected cases to neurovascular or neurosurgical specialists through a mobile application, improving workflow efficiency and potentially expediting patient care decisions. The system does not replace diagnostic evaluation but serves as a parallel workflow triage tool to alert specialists early.

The Voluson Expert 22, 20, and 18 are advanced ultrasound imaging systems designed for various clinical applications such as OB/GYN, abdominal, cardiac, and musculoskeletal imaging. They offer high-performance real-time 3D/4D imaging, Doppler modes, elastography, and incorporate AI software tools to assist clinicians in image analysis and workflow improvement, helping improve diagnostic accuracy and efficiency in hospitals and medical clinics.

BriefCase by Aidoc Medical, Ltd. is an AI-based software that helps hospitals quickly identify and prioritize urgent head CT angiography scans with possible M1 Large Vessel Occlusion. It analyzes images and sends notifications with preview images to clinicians, enabling faster triage without replacing standard image interpretation.

Rapid LVO is a software device designed to analyze CT angiography images of the head to help healthcare providers identify suspected large vessel occlusions quickly. By flagging possible cases of ICA or MCA-M1 occlusion and providing notifications with preview images, it supports faster triage and prioritization of medical images, aiding timely clinical decision-making in stroke care.

BriefCase by Aidoc Medical is an AI-powered software that analyzes non-enhanced head CT images to identify potential intracranial hemorrhage. It assists clinicians by flagging suspect cases and sending notifications with preview images to help prioritize patient care workflow. It operates alongside standard imaging interpretation without altering original medical images.

Rapid PE Triage and Notification (PETN) is an AI-powered software that analyzes CT pulmonary angiography scans to detect and notify clinicians of suspected central pulmonary embolism cases. It assists hospital networks and clinicians by prioritizing patient workflows and flagging positive findings, helping improve timely diagnosis and treatment without altering original medical images.

BriefCase by Aidoc Medical, Ltd. is an AI-powered software that analyzes contrast-enhanced chest CT scans to help hospital specialists prioritize and triage cases showing possible incidental Pulmonary Embolism. It provides notifications with compressed preview images for early attention but does not replace standard diagnostic review, working alongside existing workflows to speed up urgent case identification.

BriefCase is an AI-powered software that analyzes head CT Angio (CTA) images to assist clinicians by flagging suspected Brain Aneurysm cases above 5 mm, helping prioritize urgent cases and improving workflow efficiency. It provides notifications and preview images but is not intended for primary diagnosis, supporting clinicians to review images faster and potentially reduce time to treatment.

BriefCase is a software device that uses artificial intelligence to analyze chest X-ray images for signs of pneumothorax. It notifies trained medical specialists of suspected positive cases via a desktop app to help prioritize patient care. The software works alongside standard clinical workflows without altering the original images or diagnostic process.